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Clinical Trials/NCT01866176
NCT01866176
Completed
Not Applicable

Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait

Laval University1 site in 1 country24 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Laval University
Enrollment
24
Locations
1
Primary Endpoint
Change in Knee adduction moment
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without brace and ten with the brace.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
  • Knee pain \> 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
  • Moderately active
  • Varus knee alignment equal or superior to 2°

Exclusion Criteria

  • Severe knee OA (K-L grade IV)
  • Rheumatoid arthritis or other inflammatory arthritis
  • Avascular necrosis
  • History of periarticular fracture or septic arthritis
  • Bone metabolic disease
  • Pigmented villonodular synovitis
  • Cartilaginous disease
  • Neuropathic arthropathy
  • Synovial osteochondromatosis
  • Total or partial knee arthroplasty

Outcomes

Primary Outcomes

Change in Knee adduction moment

Time Frame: Change from Baseline at 3 months

Change in Knee pain

Time Frame: Change from Baseline at 3 months

A 20-cm visual analog scale (0-100) is used to assess pain.

Secondary Outcomes

  • Change in Spatiotemporal gait parameters(Change from Baseline at 3 months)
  • Change in Gait velocity(Change from Baseline at 3 months)
  • Change in Knee adduction angle(Change from Baseline at 3 months)
  • Change in Knee brace comfort(Change from Baseline at 3 months)

Study Sites (1)

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